Recalls / Class II
Class IID-0511-2019
Product
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
- Affected lot / code info
- Lot # 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.
Why it was recalled
Failed Stability Specification: out of specification results for Sodium Perborate
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 78120 dropper bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-02-04
- FDA classified
- 2019-02-19
- Posted by FDA
- 2019-02-27
- Terminated
- 2022-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0511-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.